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Global Regulatory Strategist (f/m/d)

Country:  Germany
City:  Aachen
Department:  Drug Safety & Regulatory Affairs
Job ID:  38115

 

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

 

 

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

  • Beeing responsible for setting the global regulatory strategy for assigned development compounds or marketed brands to deliver earliest possible approvals with a viable label closely aligned with business’ and patients’ needs 
  • Ensuring alignment and challenging the proper execution of this strategy in collaboration with cross-functional global development and brand teams, including subsidiaries
  • Coordinating the preparation of scientific advice meetings and leads negotiation of global strategies with regulatory health authorities during all stages of the life-cycle, trying to push boundaries wherever possible 
  • Co-defining the strategies for key clinical, preclinical and CMC documents as well as for briefing books, response documents etc., always taking a holistic view on scientific and commercial aspects
  • Understanding the competitive landscape and providing both business intelligence and regulatory expertise in relationship to the indication and compound, analyses trends and their impact for Grünenthal
  • Accountability for leading, developing, facilitating and coordinating the regulatory sub-team driving definition and execution of  a global project plan to smartly manage all regulatory activities
  • Managing clinical trial applications in collaboration with subsidiaries and relevant vendors
  • Providing value assessments of in- and outsourcing assets, identifying regulatory opportunities as well as regulatory risks and their potential mitigation

 

 

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

  • Scientific university degree (Master or PhD) or equivalent in life science pharmacy, biology, chemistry or related discipline)
  • Profound years of Regulatory Affairs experience in the pharmaceutical industry or at a health authority in a global setting (main territorial focus: European Union/US and Latin America, Experience in APAC beneficial), preferably experience within therapeutic area of pain and different modalities of therapy as a GRS with broad pre- and/or postmarketing experience
  • In-depth knowledge of relevant ICH/EU/US guidelines and regulations covering CMC, clinical and pre-clinical aspects
  • Track record of having delivered competitive regulatory approvals in EU/US and/or Japan
  • Excellent English communication skills, both written and verbal, German and Spanish beneficial
  • Promoting the added value of regulatory affairs for the overall business
  • Flexible, pragmatic, solution-oriented, independent and proactive working style
  • Ability to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities

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"As Global Regulatory Strategist you will drive the global regulatory strategy of our major brands and development projects for the treatment of pain and inflammation. An opportunity to work as a well-recognized function in a global cross-functional environment and with regulatory authorities worldwide, backed-up by a great team in Regulatory Affairs where people step-in for each other."

Katrin Fleischer, the Hiring Manager

About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 29 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2020, Grünenthal employed around 4,500 people and achieved sales of € 1.3 bn.

Your HR contact: 
Angelika Will

Meet our teams
Website: careers.grunenthal.com
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Website:
careers.grunenthal.com
LinkedIn:
Grunenthal Group
Instagram:
@grunenthal

Apply now

Apply for Job